Depressive and Anxiety Disorders in Patients With Chronic Liver Diseases

NCT ID: NCT06113029

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this observational study is to learn about the prevalence of depressive and anxiety disorders among patients with chronic liver diseases

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Major depressive disorder (MDD), or clinical depression, is a psychiatric disorder characterized by 2 or more weeks of persistently depressed mood accompanied by symptoms such as feelings of worthlessness, guilt, hopelessness, helplessness, loss of self-esteem, sleep disturbance, changes in oral intake, anhedonia, loss of interest, and suicidality. The american psychiatric association, on the definition of anxiety, describes anxiety as the anticipated anticipation of a future danger or negative event, accompanied by feelings of dysphoria or physical symptoms of tension. The elements exposed to risk may belong both to the internal world and to the external world. depression is highly prevalent globally and is a leading cause of disability. The global burden of disease study found depression to be a leading cause of disability among all illnesses. Liver cirrhosis is one of the diseases commonly associated with depression.chronic liver disease is the progressive destruction and regeneration of the liver parenchyma leading to fibrosis and cirrhosis (normally lasts 6 months). The etiologic agents of CLD include hepatotropic viruses (HBV and HCV), fatty liver, alcohol, autoimmune hepatitis, etc. The mortality of CLD patients remains high not only due to irreversible cirrhosis, but also multiple complications such as HCC and mental disease, especially depression. The progressive nature of this disease results in high rates of hospitalization, extensive exposure to medications, increased financial burden, frequent need for invasive procedures, changes in body image, and an increase in morbidity and mortality. All these factors contribute to the physical and psychological stress that mediates the development of depressive symptom high rates of depression have been documented in patients with decompensated liver disease and in those anticipating liver transplantation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression, Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy group

Participants not known to have neither chronic liver diseases nor Psychiatric disorders

The Hamilton Rating Scale for Anxiety

Intervention Type DIAGNOSTIC_TEST

The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).

The Beck Depression inventory

Intervention Type DIAGNOSTIC_TEST

one of the most widely used instruments for measuring the severity of depression

Rand SF-36 Questionnaire

Intervention Type DIAGNOSTIC_TEST

The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures

Diseased group

Participants known to have chronic liver diseases

The Hamilton Rating Scale for Anxiety

Intervention Type DIAGNOSTIC_TEST

The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).

The Beck Depression inventory

Intervention Type DIAGNOSTIC_TEST

one of the most widely used instruments for measuring the severity of depression

Rand SF-36 Questionnaire

Intervention Type DIAGNOSTIC_TEST

The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The Hamilton Rating Scale for Anxiety

The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).

Intervention Type DIAGNOSTIC_TEST

The Beck Depression inventory

one of the most widely used instruments for measuring the severity of depression

Intervention Type DIAGNOSTIC_TEST

Rand SF-36 Questionnaire

The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. patients admitted or attending at Rajhi university hospital with chronic liver disease including: viral (hepatitis B and C), autoimmune (primary biliary cirrhosis, primary sclerosing cholangitis and autoimmune hepatitis), non-alcoholic steatohepatitis, Morbus Wilson and cryptogenic CLD.
2. age group above 18 years old.

Exclusion Criteria

1. patients with chronic liver disease with other psychiatric disorders other than depression and anxiety.
2. patients with acute complication of chronic liver disease.
3. patients with chronic liver disease who underwent liver transplation.
4. patients with chronic liver disease under antiviral therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Salma Ashraf Mohamed Badr

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Salma Ashraf Mohamed Badr

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Salma Ashraf Mohamed Badr, MBBCH

Role: primary

01026134363

References

Explore related publications, articles, or registry entries linked to this study.

Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available.

Reference Type BACKGROUND
PMID: 24082241 (View on PubMed)

Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.

Reference Type BACKGROUND
PMID: 15939837 (View on PubMed)

Huang X, Liu X, Yu Y. Depression and Chronic Liver Diseases: Are There Shared Underlying Mechanisms? Front Mol Neurosci. 2017 May 8;10:134. doi: 10.3389/fnmol.2017.00134. eCollection 2017.

Reference Type BACKGROUND
PMID: 28533742 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Depression and liver

Identifier Type: -

Identifier Source: org_study_id